Clinical Trials

This clinical investigation is a prospective, multi-center randomized, sham control, double blinded feasibility clinical study. Both the subject and the noninvasive cardiologist that is caring for the subject will be blinded to the assigned cohort (treatment or sham). The interventional cardiologist who performs the index procedure will not be blinded.

Subjects who meet the eligibility criteria and are enrolled will be randomized 1:1 to either ablation of the right GSN using the Axon System (treatment cohort) or sham (control cohort) at the time of the procedure.

This study will enroll up to 100 subjects at an anticipated 20 US sites. Subject follow up is at 1, 3, 6, and 12 months

This is a Phase 2A, randomized, parallel-group, placebo-controlled, double-blind, within subject dose escalation trial with 3 dose levels of HU6 and placebo. Subjects will be randomized (1:1) either to HU6 or placebo. Two dose levels will be administered in sequential order (150 mg daily followed by 300 mg daily), each for 20 days, to reach the third and highest dose of 450 mg daily if safety and tolerability are demonstrated at the lower 2 preceding doses. Administration of the 450 mg high dose will continue for a total of 94 days, with a safety follow-up visit within ~14 days of the last dose.

Subjects will be screened over a 40-day period to determine their eligibility based on specific history, physical, laboratory, and imaging evaluations as per the Schedule of Assessments. While a single screening clinical site visit is indicated, an additional visit may be necessary to complete the screening procedures due to scheduling issues. A number of these assessments will serve as the baseline prior to drug administration. A central laboratory will be used for all assessments, including MRI, DEXA, clinical blood/plasma measures, transthoracic echocardiography, and CPET.

Following supine bicycle exercise hemodynamic assessment to verify eligibility, patients are sedated then randomized to the treatment or control group. Patients in both arms will undergo placement of femoral venous access sheath.

Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and Corvia Atrial Shunt implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.

Patients will be evaluated at pre-specified time intervals and followed for 5 years.

All patients will be unblinded after the 24 month follow up visit.

This study is enrolling patients who have been referred for a treadmill exercise stress test. The purpose of this study is to see if there is a relationship between the chemicals and proteins found in human blood and urine and those found in human sweat. The study will also look to see how the chemicals and proteins in human blood, urine, and sweat may change depending on if a person is at rest or doing a stressful activity such as exercising on a treadmill.

This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which is hereditary (hATTR-CM). In both cases, these changes can cause the TTR to clump and build up in certain parts of the body such as the nervous system, stomach, intestines, and heart. This build up is called an amyloid deposit. Amyloid deposits can sometimes cause heart disease or neuropathy (nerve damage). When amyloid is deposited into the heart, it can result in a condition referred to as cardiomyopathy. ION-682884 is an investigational drug. “Investigational” means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 reduces the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in the blood may reduce the amount of amyloid deposits in the body and may keep cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help cardiomyopathy. The purpose of this study is to evaluate the safety of ION-682884 and determine if it can help people with this type of cardiomyopathy.

This study is recruiting patients who have been diagnosed with Heart Failure with Preserved Ejection Fraction. The study will test whether a drug called mavacamten can lower blood levels of cardiac troponin (a marker of heart muscle injury) and/or NT-proBNP (a marker of heart wall stress). These “biomarkers” are increased in the blood of some people with HFpEF. Additionally, the main research study will provide preliminary information regarding tolerability and safety of mavacamten treatment in HFpEF. Mavacamten is an investigational drug. This means that it has not been approved by the Food and Drug Administration (FDA) or any regulatory agency for routine clinical use, including the treatment of HFpEF

Multi-center, unblinded, dose ascending, two-part pilot study involving Part A, up to 15 subjects for dose ascension and optimization (N=3 per dose level, up to 5 dose levels) and Part B, 40 patients (n=20 women, n=20 men), with a single dose of PL-3994 after which hemodynamics will be measured by pulmonary artery catheter and pulmonary artery (mixed venous) and coronary sinus blood sampling will be performed to measure cGMP levels during a 15-minute observation period.

The objective of this study is to evaluate the acute effects of a single dose of intravenous PL-3994 on hemodynamics and myocardial cGMP expression.

The following endpoints will be assessed:

• Hemodynamics (including blood pressure, right atrial pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, and cardiac output)
• Myocardial cGMP expression via coronary sinus sampling

This study is enrolling patients to use a wearable insertable cardiac monitor to better understand the various sounds that the heart makes during cardiac tests. You are being asked to participate in this study because Boston Scientific Corporation (BSC) is making a device called the insertable cardiac monitor (ICM) that measures certain heart functions. The device also works when it is placed on top of the chest. BSC made a more comfortable, wearable version of the device to use in this study. The wearable device is called the wearable cardiac monitor (WCM). As part of the study, the WCM will collect data during tests while taped to the skin. The tests include leg raise exercises, lying down, sitting and/or standing, and an optional submaximal exercise test for participants the study doctor determines appropriate. There may also be an echocardiogram during these tests. An echocardiogram takes pictures of the heart using sounds waves created by the heart. The purpose of this study is to collect data during a series of tests to see if the WCM can detect signals related to heart failure. This data will be compared to the data obtained by the echocardiogram.

A prospective cohort study applying proteomic techniques to identify blood-based biomarkers associated with worse baroreceptor reflex response to Valsalva in participants undergoing cardiac catheterization.

This study is enrolling patients at Northwestern Memorial Hospital with a history of heart failure with preserved ejection fraction and diabetes mellitus. Doctors at Northwestern University want to better understand if combining three different types of medicines at low doses into one pill can simplify and improve treatment for people who are prone to retaining fluid because of a condition called heart failure with preserved ejection fraction. Specifically, this is the most common type of heart failure and occurs with a normal ejection fraction or squeezing capacity of the heart muscle. Because patients with diabetes mellitus and heart failure with preserved ejection fraction are more likely to retain fluid, we are studying people with both of these conditions. The medicines being used in this study - bumetanide, eplerenone, and dapagliflozin- are all approved by the Food and Drug Administration (FDA) and commonly prescribed by medical providers for heart failure with preserved ejection fraction (bumetanide and eplerenone) and diabetes mellitus (dapagliflozin). In this study, they will be combined into one pill, a “Low-Dose Triple Polydiuretic Therapy” or “LDTPT” to see if LDTPT leads to reduction in NT-proBNP, a hormone which is high among persons who have heart failure with preserved ejection fraction. The (FDA) has not approved the LDTPT pill for general use and its use in this study is experimental.

This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and limited in what they can do in their daily lives. Currently, there are no approved drugs for this condition. Researchers are trying to find new therapies for this condition. The purpose of this study is to test whether Potassium Nitrate (KNO3) will improve how people with HFpEF can exercise. In HFpEF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. We do not know exactly why these limitations occur. There is some evidence that in addition to problems with the heart, patients with HFpEF also have problems with their arteries and muscles that affect their ability to exercise. Potassium Nitrate has been shown to improve how muscles work and also improve blood flow to working muscles in the body in healthy individuals. We previously conducted a pilot study with our KNO3 pills and found them to be safe in subjects with HFpEF. We would like to now study our pills in a large study to see if we can improve exercise in HFpEF. The use of Potassium Nitrate in this study is investigational. Potassium Nitrate has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study

The primary goal of this study is to investigate the prevalence of coronary microvascular dysfunction in HFpEF patients as measured by Transthoracic Doppler Echocardiography (TDE) - assisted Coronary Flow Reserve (CFR).

Outcome Paper

This study will determine the efficacy of AG10 in the treatment of subjects with symptomatic transthyretin amyloid cardiomyopathy.

This study is enrolling patient who have heart failure (inability of the heart to pump blood with normal efficiency).The purpose of this study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to your heart failure. To do this, dapagliflozin will be compared with placebo. The placebo is a pill that will look like dapagliflozin but will not have active ingredients. Dapagliflozin lowers glucose (sugar) levels in the blood by blocking the effect of specific molecules (small particles) in the body called sodium-glucose transporters. Under normal circumstances, the sodium-glucose transporters in the kidney prevent glucose in your blood stream from leaving the body through urine. Dapagliflozin inhibits the sodium-glucose transporters and lowers the blood glucose by allowing glucose removal through the urine. Dapagliflozin may also mildly decrease body weight and lower blood pressure in certain patients. Decreasing body weight and lowering blood pressure may improve the blood tests and symptoms related to heart failure.

Outcome Paper

This study examines ion exchange at the gut epithelium and microbial dysbiosis in order to understand their role in Right-Sided Heart Failure and venous congestion.

The primary objective of this non-interventional pilot study is to measure and quantify daily activity in patients with chronic heart failure under real-life conditions by already approved devices.

Outcome Paper

The primary purpose of this study is to better understand HFpEF development by investigating how sex differences between males and females affect cardiac, skeletal, vascular, and adipose tissue’s structure and function. 

MESA is a study of the characteristics of subclinical cardiovascular disease and the risk factors that predict progression to clinically overt cardiovascular disease or progression of the subclinical disease.  MESA researchers study a diverse, population-based sample of 6,814 asymptomatic men and women aged 45-84.  The heart failure ancillary study aims to determine the prevalence, pathogenesis, and phenomics of early heart failure among 3,500 older adults attending the MESA Year-15 exam.

Outcome Paper

Real Life Multimarker Monitoring in Patients with Heart Failure

A long-term, multicenter, single-arm, open-label extension of the SERENADE study, to assess the safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease

The primary objective of this trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction ≥40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).  Participants will be randomized 1:1 to an Implant Group or a non-implant Control group, and then followed for 1 year and annually every 12 months for a total of 5 years after index procedure and implant. Participants in the control group will have the option to cross-over to receive the study device after the 24 month visit.

Outcome Paper

The purpose of this study is to look at the efficacy and safety of the “Study Drug” neladenoson bialanate (BAY 1067197), and to learn more about how the body processes it. This study is recruiting patients who have heart failure with normal ejection fraction (a measurement of the percentage of blood leaving the heart each time it pumps). 

Outcome Paper

The purpose of this research study is to compare the effects over 30 months of the study drug, tafamidis meglumine (hereafter called tafamidis) at two different doses (20 mg and 80 mg) with placebo to find out which is better for treating TTR-CM.

Outcome Paper

The purpose of this research study is to test if 200 mg of LCZ696 twice a day, compared to 160 mg of valsartan twice a day, is safe and effective in reducing the complications of heart failure, such as hospitalization for heart failure and death from cardiovascular causes. 

Outcome Paper

The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the Corvia Medical, Inc. IASD® System II (“the study device”) in the treatment of patients with heart failure symptoms and relatively normal pumping of the heart.

Outcome Paper

The purpose of this study is to test if an investigational study drug, Inorganic Sodium Nitrite Solution (AIR-001) inhaled through a nebulizer (a hand held breathing device), is safe and can improve the ability to tolerate all forms of physical activity including exercise and thus improve quality of life in people who have chronic heart failure.  

Outcome Paper

The objective of this study is to evaluate the safety and efficacy of 3 dose levels of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.

Outcome Paper

The primary objective of this study is to evaluate the safety and tolerability of AG10 administered to adult patients with symptomatic transthyretin amyloid cardiomyopathy (ATTRCM).

Outcome Paper

The purpose of this study is to collect information on patients who have transthyretin-associated amyloidosis in order to understand the disease better and improve the care of patients.

Outcome Paper

The purpose of this study is to better understand how the heart’s health and function is affected by HIV infection and use of active antiretroviral therapy.

Outcome Paper

The purpose of the study is to determine if an investigational drug called CLR325 (“the study drug”) is safe and tolerable in heart failure patients.  This is the first time it will be studied in patients with heart failure.

This is a longitudinal, multi-center, study exploring blood expression levels of a predefined set of disease and fibrosis biomarkers in post-ADHF patients, stable HF patients and hypertensive subjects without heart failure.

The purpose of this study is to learn more about the safety and effects of the study drug, tafamidis meglumine, to find the best dose for treating transthyretin amyloid cardiomyopathy (TTR-CM), and to provide participants of this study with tafamidis following completion of that protocol. Participants in this extension will be followed for up to 60 months, with clinic visits and telephone contacts every 6 months.

Outcome Paper

This study examines the genetic determinants of cardiac contractility.  Specifically, the focus of this study is to search for quantitative trait loci in the human genome and then identify specific SNPs within these loci that influence cardiac contractility.

Outcome Paper

The purpose of this study is to find out whether a drug called “macitentan” works and is safe in patients with Heart Failure with Preserved Ejection Fraction and Pulmonary Vascular Disease.

REVAMP is a feasibility study in heart failure with preserved ejection fraction (HFpEF) patients who have normal to small left ventricular volumes and evidence of hypertrophy. The pacemaker Sleep function will be used in order to deliver a 5 hour block of sustained pacing at 100 bpm during the night for 4-8 weeks. The purpose is to investigate whether this elevated pacing therapy is tolerated and whether there is a signal of efficacy.

An Open-Label Extension and Safety Monitoring Study of Patients with Symptomatic Transthyretin Cardiomyopathy Who Have Completed the Phase II Study AG10-201

A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

INTREPID: A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients

An Open-Label Rollover Study of Levosimendan in Patients with Pulmonary Hypertension with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)